Japan Tobacco files for Japanese approval of elvitegravir

Japan Tobacco (TSE:2914) has filed a New Drug Application for marketing approval of a novel anti-HIV single tablet regimen containing JT’s original compound JTK-303 (elvitegravir) with the Japanese Ministry of Health, Labour and Welfare.

The complete, once-daily, single-tablet regimen contains elvitegravir, an integrase inhibitor; cobicistat, a pharmaco-enhancing or “boosting” agent that increases blood levels of elvitegravir; emtricitabine (Emtriva 200mg capsule) and tenofovir disoproxil fumarate (Viread 300mg tablet). The US Food and Drug Administration approved this fixed-dose, single-tablet regimen, under the trade name Stribild (The Pharma Letter August 29). JT licensed elvitegravir to Gilead, the manufacturer of both Emtriva and Viread, in 2005 with exclusive rights to develop and commercialize the drug worldwide, excluding Japan.

If approved, the product would be the only once-daily, single-tablet regimen to be commercialized in Japan. While combination antiretroviral therapy has been a standard of care for HIV infection, this single-tablet regimen is expected to provide patients’ convenience and long-term drug adherence.